Cost-effectiveness of daclatasvir plus sofosbuvir-based regimen for treatment of hepatitis C virus genotype 3 infection in Canada.

OBJECTIVE: New regimens for the treatment of chronic hepatitis C virus (HCV) genotype 3 have demonstrated substantial improvement in sustained virologic response (SVR) compared with existing therapies, but are considerably more expensive. The objective of this study was to evaluate the cost-effectiveness of two novel all-oral, interferon-free regimens for the treatment of patients with HCV genotype 3: daclatasvir plus sofosbuvir (DCV + SOF) and sofosbuvir plus ribavirin (SOF + RBV), from a Canadian health-system perspective. METHODS: A decision analytic Markov model was developed to compare the effect of various treatment strategies on the natural history of the disease and their associated costs in treatment-naïve and treatment-experienced patients. Patients were initially distributed across fibrosis stages F0-F4, and may incur disease progression through fibrosis stages and on to end-stage liver disease complications and death; or may achieve SVR. Clinical efficacy, health-related quality-of-life, costs, and transition probabilities were based on published literature. Probabilistic sensitivity analysis was performed to assess parameter uncertainty associated with the analysis. RESULTS: In treatment-naive patients, the expected quality-adjusted life years (QALYs) for interferon-free regimens were higher for DCV + SOF (12.37) and SOF + RBV (12.48) compared to that of pINF + RBV (11.71) over a lifetime horizon, applying their clinical trial treatment durations. The expected costs were higher for DCV + SOF ($170,371) and SOF + RBV ($194,776) vs pINF + RBV regimen ($90,905). Compared to pINF + RBV, the incremental cost-effectiveness ratios (ICER) were $120,671 and $135,398 per QALYs for DCV + SOF and SOF + RBV, respectively. In treatment-experienced patients, DCV + SOF regimen dominated the SOF + RBV regimen. Probabilistic sensitivity analysis indicated a 100% probability that a DCV + SOF regimen was cost saving in treatment-experienced patients. CONCLUSION: Daclatasvir plus sofosbuvir is a safe and effective option for the treatment of chronic HCV genotype 3 patients. This regimen could be considered a cost-effective option following a first-line treatment of peg-interferon/ribavirin treatment experienced patients with HCV genotype-3 infection.

Systematic narrative review of decision frameworks to select the appropriate modelling approaches for health economic evaluations.

BACKGROUND: In constructing or appraising a health economic model, an early consideration is whether the modelling approach selected is appropriate for the given decision problem. Frameworks and taxonomies that distinguish between modelling approaches can help make this decision more systematic and this study aims to identify and compare the decision frameworks proposed to date on this topic area. METHODS: A systematic review was conducted to identify frameworks from peer-reviewed and grey literature sources. The following databases were searched: OVID Medline and EMBASE; Wiley's Cochrane Library and Health Economic Evaluation Database; PubMed; and ProQuest. RESULTS: Eight decision frameworks were identified, each focused on a different set of modelling approaches and employing a different collection of selection criterion. The selection criteria can be categorized as either: (i) structural features (i.e. technical elements that are factual in nature) or (ii) practical considerations (i.e. context-dependent attributes). The most commonly mentioned structural features were population resolution (i.e. aggregate vs. individual) and interactivity (i.e. static vs. dynamic). Furthermore, understanding the needs of the end-users and stakeholders was frequently incorporated as a criterion within these frameworks. CONCLUSIONS: There is presently no universally-accepted framework for selecting an economic modelling approach. Rather, each highlights different criteria that may be of importance when determining whether a modelling approach is appropriate. Further discussion is thus necessary as the modelling approach selected will impact the validity of the underlying economic model and have downstream implications on its efficiency, transparency and relevance to decision-makers.

Evaluation of a chronic disease management system for the treatment and management of diabetes in primary health care practices in Ontario: an observational study.

BACKGROUND: Computerized chronic disease management systems (CDMSs), when aligned with clinical practice guidelines, have the potential to effectively impact diabetes care. OBJECTIVE: The objective was to measure the difference between optimal diabetes care and actual diabetes care before and after the introduction of a computerized CDMS. METHODS: This 1-year, prospective, observational, pre/post study evaluated the use of a CDMS with a diabetes patient registry and tracker in family practices using patient enrolment models. Aggregate practice-level data from all rostered diabetes patients were analyzed. The primary outcome measure was the change in proportion of patients with up-to-date "ABC" monitoring frequency (i.e., hemoglobin A1c, blood pressure, and cholesterol). Changes in the frequency of other practice care and treatment elements (e.g., retinopathy screening) were also determined. Usability and satisfaction with the CDMS were measured. RESULTS: Nine sites, 38 health care providers, and 2,320 diabetes patients were included. The proportion of patients with up-to-date ABC (12%), hemoglobin A1c (45%), and cholesterol (38%) monitoring did not change over the duration of the study. The proportion of patients with up-to-date blood pressure monitoring improved, from 16% to 20%. Data on foot examinations, retinopathy screening, use of angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, and documentation of self-management goals were not available or not up to date at baseline for 98% of patients. By the end of the study, attitudes of health care providers were more negative on the Training, Usefulness, Daily Practice, and Support from the Service Provider domains of the CDMS, but more positive on the Learning, Using, Practice Planning, CDMS, and Satisfaction domains. LIMITATIONS: Few practitioners used the CDMS, so it was difficult to draw conclusions about its efficacy. Simply giving health care providers a potentially useful technology will not ensure its use. CONCLUSIONS: This real-world evaluation of a web-based CDMS for diabetes failed to impact physician practice due to limited use of the system. PLAIN LANGUAGE SUMMARY: Patients and health care providers need timely access to information to ensure proper diabetes care. This study looked at whether a computer-based system at the doctor's office could improve diabetes management. However, few clinics and health care providers used the system, so no improvement in diabetes care was seen.

Point-of-Care Hemoglobin A1c Testing: A Budget Impact Analysis.

BACKGROUND: The increasing prevalence of diabetes in Ontario means that there will be growing demand for hemoglobin A1c (HbA1c) testing to monitor glycemic control as part of managing this chronic disease. Testing HbA1c where patients receive their diabetes care may improve system efficiency if the results from point-of-care HbA1c testing are comparable to those from laboratory HbA1c measurements. OBJECTIVES: To estimate the budget impact of point-of-care HbA1c testing to replace laboratory HbA1c measurement for monitoring glycemic control in patients with diabetes in 2013/2014. REVIEW METHODS: This analysis compared the average testing cost of 3 point-of-care HbA1c devices licensed by Health Canada and available on the market in Canada (Bayer's A1cNow+, Siemens's DCA Vantage, and Bio Rad's In2it), with that of the laboratory HbA1c reference method. The cost difference between point-of-care HbA1c testing and laboratory HbA1c measurement was calculated. Costs and the corresponding range of net impact were estimated in sensitivity analyses. RESULTS: The total annual costs of laboratory HbA1c measurement and point-of-care HbA1c testing for 2013/2014 were $91.5 million and $86.8 million, respectively. Replacing all laboratory HbA1c measurements with point-of-care HbA1c testing would save approximately $4.7 million over the next year. Savings could be realized by the health care system at each level that point-of-care HbA1c testing is substituted for laboratory HbA1c measurement. If physician fees were excluded from the analysis, the health care system would incur a net impact from using point-of-care HbA1c testing instead of laboratory A1c measurement. LIMITATIONS: Point-of-care HbA1c technology is already in use in the Ontario health care system, but the current uptake is unclear. Knowing the adoption rate and market share of point-of-care HbA1c technology would allow for a more accurate estimate of budget impact. CONCLUSIONS: Replacing laboratory HbA1c measurement with point-of-care HbA1c testing or using point-of-care HbA1c testing in combination with laboratory HbA1c measurement to monitor glycemic control in patients with diabetes could have saved the province $1,175,620 to $4,702,481 in 2013/2014.

Cost-effectiveness of the carbon-13 urea breath test for the detection of Helicobacter pylori: an economic analysis.

OBJECTIVES: This analysis aimed to evaluate the cost-effectiveness of various testing strategies for Helicobacter pylori in patients with uninvestigated dyspepsia and to calculate the budgetary impact of these tests for the province of Ontario. DATA SOURCES: Data on the sensitivity and specificity were obtained from the clinical evidence-based analysis. Resource items were obtained from expert opinion, and costs were applied on the basis of published sources as well as expert opinion. REVIEW METHODS: A decision analytic model was constructed to compare the costs and outcomes (false-positive results, false-negative results, and misdiagnoses avoided) of the carbon-13 (¹³C) urea breath test (UBT), enzyme-linked immunosorbent assay (ELISA) serology test, and a 2-step strategy of an ELISA serology test and a confirmatory ¹³C UBT based on the sensitivity and specificity of the tests and prevalence estimates. RESULTS: The 2-step strategy is more costly and more effective than the ELISA serology test and results in $210 per misdiagnosis case avoided. The ¹³C UBT is dominated by the 2-step strategy, i.e., it is more costly and less effective. The budget impact analysis indicates that it will cost $7.9 million more to test a volume of 129,307 patients with the ¹³C UBT than with ELISA serology, and $4.7 million more to test these patients with the 2-step strategy. LIMITATIONS: The clinical studies that were pooled varied in the technique used to perform the breath test and in reference standards used to make comparisons with the breath test. However, these parameters were varied in a sensitivity analysis. The economic model was designed to consider intermediate outcomes only (i.e., misdiagnosed cases) and was not a complete model with final patient outcomes (e.g., quality-adjusted life years). CONCLUSIONS: Results indicate that the 2-step strategy could be economically attractive for the testing of H. pylori. However, testing with the 2-step strategy will cost the Ministry of Health and Long-Term Care $4.7 million more than with the ELISA serology test.

Transcatheter aortic valve implantation (TAVI) for treatment of aortic valve stenosis: an evidence update.

BACKGROUND: One-year mortality outcomes in the PARTNER trial showed that transcatheter aortic valve implantation (TAVI) was noninferior to surgical aortic valve replacement (sAVR) in patients who were eligible for sAVR (cohort A), and superior to standard treatment in patients who were ineligible for sAVR (cohort B). OBJECTIVE: To update a previous report on the safety, effectiveness, and cost-effectiveness of TAVI, published in 2012. DATA SOURCES: A literature search was performed on September 11, 2012, using OVID MEDLINE, OVID MEDLINE In-Process and Other Non-Indexed Citations, OVID EMBASE, EBSCO Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Wiley Cochrane Library, and the Centre for Reviews and Dissemination database, for studies published from January 1, 2011, until September 11, 2012. REVIEW METHODS: Randomized controlled trials investigating TAVI in comparison to sAVR or standard treatment were included for analysis. Results were summarized descriptively. RESULTS: At 2-year follow-up, mortality in cohort A was similar between the TAVI and sAVR groups. Rates of stroke/transient ischemic attack, major vascular complications, and moderate/severe paravalvular aortic regurgitation were significantly higher in the TAVI group, but rate of major bleeding was significantly higher in the sAVR group. Mortality in cohort B was significantly lower with transfemoral (TF) TAVI than with standard treatment, but rate of stroke was significantly higher with TF TAVI. TF TAVI resulted in a more rapid improvement in quality of life scores than sAVR, but this difference was not sustained at 6 and 12 months. Patients who underwent transapical TAVI did not have a greater early improvement in quality of life compared to sAVR patients. Compared to standard treatment, TF TAVI resulted in a greater improvement in quality of life scores at all time points. Incremental cost-effectiveness ratios were in favour of TAVI for inoperable patients in the base-case analysis, but varied widely for operable patients. CONCLUSIONS: The findings of the 2-year follow-up with respect to mortality and adverse events were consistent with those of the 1-year follow-up. TAVI was also associated with improvement in quality of life, although results varied by cohort. Consistent with the 2012 report, TAVI may be cost-effective for patients who are not candidates for surgery.

Estimating the excess costs for patients with incident fractures, prevalent fractures, and nonfracture osteoporosis.

SUMMARY: Based on a population age 50+, significant excess costs relative to matched controls exist for patients with incident fractures that are similar in relative magnitude to other chronic diseases such as stroke or heart disease. Prevalent fractures also have significant excess costs that are similar in relative magnitude to asthma/chronic obstructive pulmonary disease. INTRODUCTION: Cost of illness studies for osteoporosis that only include incident fractures may ignore the long-term cost of prevalent fractures and primary preventive care. We estimated the excess costs for patients with incident fractures, prevalent fractures, and nonfracture osteoporosis relative to matched controls. METHODS: Men and women age 50+ were selected from administrative records in the province of Manitoba, Canada for the fiscal year 2007-2008. Three types of cases were identified: (1) patients with incident fractures in the current year (2007-2008), (2) patients with prevalent fractures in previous years (1995-2007), and (3) nonfracture osteoporosis patients identified by specific pharmacotherapy or low bone mineral density. Excess resource utilization and costs were estimated by subtracting control means from case means. RESULTS: Seventy-three percent of provincial population age 50+ (52 % of all men and 91 % of all women) were included (121,937 cases, 162,171 controls). There were 3,776 cases with incident fracture (1,273 men and 2,503 women), 43,406 cases with prevalent fractures (15,784 men and 27,622 women) and 74,755 nonfracture osteoporosis cases (7,705 men and 67,050 women). All incident fractures had significant excess costs. Incident hip fractures had the highest excess cost: men $44,963 (95 % CI: $38,498-51,428) and women $45,715 (95 % CI: $36,998-54,433). Prevalent fractures (other than miscellaneous or wrist fractures) also had significant excess costs. No significant excess costs existed for nonfracture osteoporosis. CONCLUSION: Significant excess costs exist for patients with incident fractures and with prevalent hip, vertebral, humerus, multiple, and traumatic fractures. Ignoring prevalent fractures underestimate the true cost of osteoporosis.

Vitamin B12 intramuscular injections versus oral supplements: a budget impact analysis.

BACKGROUND: Vitamin B12 deficiency can lead to adverse health effects such as anemia and, in some cases, permanent neurologic damage. In Canada, patients with vitamin B12 deficiency are typically given intramuscular injections, which incur considerable cost and inconvenience. The clinical evidence-based analysis has found that oral supplementation is as effective as intramuscular injections. OBJECTIVES: This economic analysis aimed to estimate the cost savings of switching from intramuscular injections to high-dose oral supplements for patients aged 18 years and older with confirmed vitamin B12 deficiency. DATA SOURCES: Population-based administrative databases for Ontario were used to identify patients receiving vitamin B12 intramuscular injections in any fiscal year between 2006 and 2011. The Ontario Drug Benefit (ODB) database was used to identify patients who were prescribed vitamin B12 injections, and the Ontario Health Insurance Plan database was used to identify all physician claims for intramuscular injections as well as laboratory tests assessing vitamin B12 levels. The Registered Physicians Database was used to identify the type of physician; the analysis was restricted to family physicians and internists. REVIEW METHODS: Two cohorts of patients were identified. For cohort 1, the ODB database was used to identify patients who were prescribed vitamin B12 injections. Those covered under the ODB are 65 years of age or older and are economically deprived. A second cohort was created to capture those 18 to 64 years of age receiving injections. Cohort 2 consisted of patients (not in cohort 1) who received 6 or more intramuscular injections within 1 year and had a laboratory test 2 months before the intramuscular injection claim. Physician experts were consulted to estimate the resources and costs of converting patients to oral supplements. The Ministry of Health and Long-Term Care perspective was taken, and all costs are expressed in 2013 Canadian dollars. RESULTS: The budget impact analysis demonstrated costs of $2.8 million to the Ministry of Health and Long-Term Care in the first year of conversion; however, in subsequent years there are savings of $4.2 million per year. The cumulative 5-year budget impact demonstrates savings of $14.2 million to the health care system. LIMITATIONS: This analysis represents the cost of conversion for those currently receiving intramuscular injections. There are no conversion costs for those who are prescribed oral supplements as an initial therapy, and so the savings could be even greater than reported. As well, an underlying assumption of this analysis is that patients will comply with oral supplementation. CONCLUSIONS: Over 5 years, there are savings of $14.2 million to the health care system from switching to vitamin B12 oral supplements. PLAIN LANGUAGE SUMMARY: Vitamin B12 deficiency has long been thought to be associated with dementia and other neurocognitive disorders. In a separate report, Health Quality Ontario (HQO) reviewed the published research on this issue and found only weak evidence that vitamin B12 deficiency is associated with the onset of dementia. That review also found moderate evidence that treatment with vitamin B12 does not improve dementia and that oral supplements are as effective as injections of vitamin B12. In 2010, more than 2.9 million serum vitamin B12 tests were performed in Ontario at a cost of $40 million. Each year, approximately 110,000 residents receive vitamin B12 injections to boost their levels of vitamin B12. HQO commissioned an economic analysis to estimate the cost savings of switching from vitamin B12 injections to high-dose oral supplements for patients aged 18 years and older with confirmed B12 deficiency. This study concluded that the Ontario health care system could save $14.5 million in 5 years by switching to oral supplements, assuming that patients took the oral supplements as required.

Transcatheter aortic valve implantation (TAVI) for treatment of aortic valve stenosis: an evidence-based Analysis (part B).

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become an alternative to surgical aortic valve replacement (sAVR) for patients at high risk for surgery. OBJECTIVE: To evaluate the safety, effectiveness, and cost-effectiveness of TAVI for treatment of aortic valve stenosis in symptomatic older adults. REVIEW METHODS: A literature search was performed on September 6, 2011, for studies published from January 1, 2007, to September 6, 2011. A combined decision tree and Markov model was developed to compare costs, life years, and quality-adjusted life-years (QALYs) of all treatment options in their respective patient populations over a 20-year time horizon. RESULTS: Two studies from the PARTNER trial were identified. The first study compared TAVI to sAVR in patients who were candidates for sAVR. The second study compared TAVI to standard treatment in patients who were not eligible for sAVR. The first study showed that TAVI and sAVR had similar mortality rates at 1 year. The second study showed a significant improvement in patient survival in those undergoing TAVI. However, in both studies, the TAVI group had significantly higher rates of stroke/transient ischemic attack, and major vascular complications. Rates of major bleeding were significantly higher in sAVR group in the first study and significantly higher in TAVI group in the second study. The base-case cost-effectiveness of TAVI was $48,912 per QALY, but the incremental cost-effectiveness ratio ranged from $36,000 to $291,000 per QALY depending on the assumptions made in the longer-term prediction portion of the model (i.e., beyond the follow-up period of the PARTNER trial). CONCLUSIONS: TAVI improves survival in patients who cannot undergo surgery. For those who are candidates for surgery, TAVI has a mortality rate similar to sAVR, but it is associated with significant adverse effects. TAVI may be cost-effective for patients who cannot undergo surgery, but is not cost-effective for patients who can.

Cost-effectiveness of denosumab in the treatment of postmenopausal osteoporosis in Canada.

OBJECTIVE: Denosumab is a novel biologic agent approved in Canada for treatment of post-menopausal osteoporosis (PMO) in women at high risk for fracture or who have failed or are intolerant to other osteoporosis therapies. This study estimated cost-effectiveness of denosumab vs usual care from the perspective of the Ontario public payer. METHODS: A previously published PMO Markov cohort model was adapted for Canada to estimate cost-effectiveness of denosumab. The primary analysis included women with demographic characteristics similar to those from the pivotal phase III denosumab PMO trial (FREEDOM; age 72 years, femoral neck BMD T-score -2.16 SD, vertebral fracture prevalence 23.6%). Three additional scenario sub-groups were examined including women: (1) at high fracture risk, defined in FREEDOM as having at least two of three risk factors (age 70+; T-score ≤ -3.0 SD at lumbar spine, total hip, or femoral neck; prevalent vertebral fracture); (2) age 75+; and (3) intolerant or contraindicated to oral bisphosphonates (BPs). Analyses were conducted over a lifetime horizon comparing denosumab to usual care ('no therapy', alendronate, risedronate, or raloxifene [sub-group 3 only]). The analysis considered treatment-specific persistence and post-discontinuation residual efficacy, as well as treatment-specific adverse events. Both deterministic and probabilistic sensitivity analyses were conducted. RESULTS: The multi-therapy comparisons resulted in incremental cost-effectiveness ratios for denosumab vs alendronate of $60,266 (2010 CDN$) (primary analysis) and $27,287 per quality-adjusted life year gained for scenario sub-group 1. Denosumab dominated all therapies in the remaining scenarios. LIMITATIONS: Key limitations include a lack of long-term, real-world, Canadian data on persistence with denosumab as well as an absence of head-to-head clinical data, leaving one to rely on meta-analyses based on trials comparing treatment to placebo. CONCLUSIONS: Denosumab may be cost-effective compared to oral PMO treatments for women at high risk of fractures and those who are intolerant and/or contraindicated to oral BPs.

The burden of illness of osteoporosis in Canada.

UNLABELLED: To update the 1993 burden of illness of osteoporosis in Canada, administrative and community data were used to calculate the 2010 costs of osteoporosis at $2.3 billion in Canada or 1.3% of Canada's healthcare expenditures. Prevention of fractures in high-risk individuals is key to decrease the financial burden of osteoporosis. INTRODUCTION: Since the 1996 publication of the burden of osteoporosis in 1993 in Canada, the population has aged and the management of osteoporosis has changed. The study purpose was to estimate the current burden of illness due to osteoporosis in Canadians aged 50 and over. METHODS: Analyses were conducted using five national administrative databases from the Canadian Institute for Health Information for the fiscal-year ending March 31 2008 (FY 2007/2008). Gaps in national data were supplemented by provincial and community data extrapolated to national levels. Osteoporosis-related fractures were identified using a combination of most responsible diagnosis at discharge and intervention codes. Fractures associated with severe trauma codes were excluded. Costs, expressed in 2010 dollars, were calculated for osteoporosis-related hospitalizations, emergency care, same day surgeries, rehabilitation, continuing care, homecare, long-term care, prescription drugs, physician visits, and productivity losses. Sensitivity analyses were conducted to measure the impact on the results of key assumptions. RESULTS: Osteoporosis-related fractures were responsible for 57,413 acute care admissions and 832,594 hospitalized days in FY 2007/2008. Acute care costs were estimated at $1.2 billion. When outpatient care, prescription drugs, and indirect costs were added, the overall yearly cost of osteoporosis was over $2.3 billion for the base case analysis and as much as $3.9 billion if a proportion of Canadians were assumed to be living in long-term care facilities due to osteoporosis. CONCLUSIONS: Osteoporosis is a chronic disease that affects a large segment of the adult population and results in a substantial economic burden to the Canadian society.

Estimation of the lifetime risk of hip fracture for women and men in Canada.

UNLABELLED: In Canada in 2008, based on current rates of fracture and mortality, a woman or man at age 50 years will have a projected lifetime risk of fracture of 12.1% and 4.6%, respectively, and 8.9% and 6.7% after incorporating declining rates of hip fracture and increases in longevity. INTRODUCTION: In 1989, the lifetime risk of hip fractures in Canada was 14.0% (women) and 5.2% (men). Since then, there have been changes in rates of hip fracture and increased longevity. We update these estimates to 2008 adjusted for these trends, and in addition, we estimated the lifetime risk of first hip fracture. METHODS: We used national administrative data from fiscal year April 1, 2007 to March 31, 2008 to identify all hip fractures in Canada. We estimated the crude lifetime risk of hip fracture for age 50 years to end of life using life tables. We projected lifetime risk incorporating national trends in hip fracture and increased longevity from Poisson regressions. Finally, we removed the percentage of second hip fractures to estimate the lifetime risk of first hip fracture. RESULTS: From April 1, 2007 to March 31, 2008, there were 21,687 hip fractures, 15,742 (72.6%) in women and 5,945 (27.4%) in men. For women and men, the crude lifetime risk was 12.1% (95%CI, 12.1, 12.2%) and 4.6% (95%CI, 4.5, 4.7%), respectively. When trends in mortality and hip fractures were both incorporated, the lifetime risk of hip fracture were 8.9% (95%CI, 2.3, 15.4%) and 6.7% (95%CI, 1.2, 12.2%). The lifetime risks for first hip fracture were 7.3% (95%CI, 0.8, 13.9%) and 6.2% (95%CI, 0.7, 11.7%). CONCLUSIONS: The lifetime risk of hip fracture has fallen from 1989 to 2008 for women and men. Adjustments for trends in mortality and rates of hip fracture with removing second fractures produced non-significant differences in estimates.

Estimating the national wage loss from cancer in Canada.

OBJECTIVES: Using primary and secondary data sources, we set out to estimate the Canadian wage loss from cancer for patients, caregivers, and parents from a patient and a societal perspective. METHODS: First, a multiple-database literature search was conducted to find Canadian-specific direct surveys of wage loss from cancer. Second, estimates for wage loss were generated from the nationally representative Canadian Community Health Survey (CCHS) Cycle 3.1. In addition, both estimates were standardized to derive a friction-period estimate and were extrapolated to produce national annual estimates. RESULTS: The literature search identified six direct surveys that included a total of 1632 patients with cancer. The CCHS Cycle 3.1 included 2287 patients with cancer. Overall, based on the direct surveys, newly diagnosed cancer patients reduced their labour participation in the friction period by 36% ($4,518), and caregivers lost 23% of their workable hours ($2,887). The CCHS estimated that annual household income was 26.5% lower ($4,978) for respondents with cancer as compared with the general population. For the year 2009, results from direct surveys indicated that new cancers in Canada generated a wage loss of $3.18 billion; the CCHS Cycle 3.1 estimate was $2.95 billion. CONCLUSIONS: Wage loss from cancer is a significant economic burden on patients, their families, and society in Canada, with direct surveys and the CCHS providing similar estimates.

Community-based intervention to optimise falls risk management: a randomised controlled trial.

BACKGROUND: falls are the leading causes of accidental death and fragility fractures in older adults. Interventions that assess and reduce falls risk are underutilised. OBJECTIVE: to evaluate the impact of a multifaceted community-based programme aimed at optimising evidence-based management of patients at risk for fall-related fractures. DESIGN: this was a randomised trial performed from 2003 to 2006. SETTING: community-based intervention in Ontario, Canada. PARTICIPANTS: eligible patients were community-dwelling, aged > or =55 years and identified to be at risk for fall-related fractures. A total of 201 patients were allocated to the intervention group or to usual care. INTERVENTION: components of the intervention included assessment of falls risk, functional status and home environment, and patient education. MEASUREMENTS: primary outcome was the implementation of appropriate falls risk assessment at 6 months. Secondary outcomes included falls and fractures at 6 and 12 months. RESULTS: the mean age of participants was 72 years, and 41% had fallen with injury in the previous year. Compared to usual care, the intervention increased the number of referrals made to physiotherapy [21% (21/101) vs 6.0% (6/100); relative risk (RR) 3.47, 95% confidence interval (CI) 1.46-8.22] and occupational therapy [15% (15/101) vs 0%; RR 30.7, 95% CI 1.86 to >500]. At 12 months, the number of falls in the intervention group was greater than in the usual care group [23% (23/101) vs 11% (11/100); RR 2.07, 95% CI 1.07-4.02]. CONCLUSIONS: compared to usual care, a multi-faceted intervention increased referrals to physiotherapy and occupational therapy but did not reduce risk of falls. Similar falls reduction interventions cannot be recommended based on the results of this study.

Community-based randomised controlled trial evaluating falls and osteoporosis risk management strategies.

BACKGROUND: Osteoporosis-related fractures are a significant public health concern. Interventions that increase detection and treatment of osteoporosis, as well as prevention of fractures and falls, are substantially underutilized. This paper outlines the protocol for a pragmatic randomised trial of a multifaceted community-based care program aimed at optimizing the evidence-based management of falls and fractures in patients at risk. DESIGN: 6-month randomised controlled study. METHODS: This population-based study was completed in the Algoma District of Ontario, Canada a geographically vast area with Sault Ste Marie (population 78,000) as its main city. Eligible patients were allocated to an immediate intervention protocol (IP) group, or a delayed intervention protocol (DP) group. The DP group received usual care for 6 months and then was crossed over to receive the interventions. Components of the intervention were directed at the physicians and their patients and included patient-specific recommendations for osteoporosis therapy as outlined by the clinical practice guidelines developed by Osteoporosis Canada, and falls risk assessment and treatment. Two primary outcomes were measured including implementation of appropriate osteoporosis and falls risk management. Secondary outcomes included quality of life and the number of falls, fractures, and hospital admissions over a twelve-month period. The patient is the unit of allocation and analysis. Analyses will be performed on an intention to treat basis. DISCUSSION: This paper outlines the protocol for a pragmatic randomised trial of a multi-faceted, community-based intervention to optimize the implementation of evidence based management for patients at risk for falls and osteoporosis. TRIAL REGISTRATION: This trial has been registered with clinicaltrials.gov (ID: NCT00465387).

The economic burden of schizophrenia in Canada in 2004.

OBJECTIVE: To estimate the financial burden of schizophrenia in Canada in 2004. METHODS: A prevalence-based cost-of-illness (COI) approach was used. The primary sources of information for the study included a review of the published literature, a review of published reports and documents, secondary analysis of administrative datasets, and information collected directly from various federal and provincial government programs and services. The literature review included publications up to April 2005 reported in MedLine, EMBASE and PsychINFO. Where specific information from a province was not available, the method of mean substitution from other provinces was used. Costs incurred by various levels/departments of government were separated into healthcare and non-healthcare costs. Also included in the analysis was the value of lost productivity for premature mortality and morbidity associated with schizophrenia. Sensitivity analysis was used to test major cost assumptions used in the analysis. Where possible, all resource utilization estimates for the financial burden of schizophrenia were obtained for 2004 and are expressed in 2004 Canadian dollars (CAN dollars). RESULTS: The estimated number of persons with schizophrenia in Canada in 2004 was 234 305 (95% CI, 136 201-333 402). The direct healthcare and non-healthcare costs were estimated to be 2.02 billion CAN dollars in 2004. There were 374 deaths attributed to schizophrenia. This combined with the high unemployment rate due to schizophrenia resulted in an additional productivity morbidity and mortality loss estimate of 4.83 billion CAN dollars, for a total cost estimate in 2004 of 6.85 billion CAN dollars. By far the largest component of the total cost estimate was for productivity losses associated with morbidity in schizophrenia (70% of total costs) and the results showed that total cost estimates were most sensitive to alternative assumptions regarding the additional unemployment due to schizophrenia in Canada. CONCLUSIONS: Despite significant improvements in the past decade in pharmacotherapy, programs and services available for patients with schizophrenia, the economic burden of schizophrenia in Canada remains high. The most significant factor affecting the cost of schizophrenia in Canada is lost productivity due to morbidity. Programs targeted at improving patient symptoms and functioning to increase workforce participation has the potential to make a significant contribution in reducing the cost of this severe mental illness in Canada.

Cost-effectiveness of screening swab or urine specimens for Chlamydia trachomatis from young Canadian women in Ontario.

BACKGROUND: Undetected and untreated Chlamydia trachomatis infections can result in a significant health burden. Diagnostic testing refers to tests performed on patients with symptoms, whereas screening refers to testing specimens in asymptomatic patients. The goal of diagnostic testing and screening programs are early identification of infections to prevent upper tract infection and transmission to other partners. GOAL: To compare the costs and outcomes of alternative diagnostic testing and screening programs for women ages 15 to 24 years in the province of Ontario, Canada. STUDY DESIGN: Using outcome probabilities from the literature and a consensus group, together with the costs from insurance billing, a decision analytic model was constructed to determine the baseline risk of C trachomatis and related sequelae. Seven diagnostic testing and screening programs were compared over a 10-year period. The programs compared included the use of nucleic acid amplification assays collected from urine or endocervical swab specimens. RESULTS: Largely because of lower sensitivity the urine-based testing or screening programs were dominated by the swab-based programs. The move from swab-based testing to a swab-based screening program for high-risk women costs $1873 per case of C trachomatis averted. Expanding the program further to include all women in Ontario between 15 and 24 years of age is considerably more costly at $5990 per case averted. CONCLUSIONS: It is more costly and more effective to screen and treat high-risk women ages 15 to 24 years for C trachomatis than to perform only swab-based diagnostic testing on symptomatic women. Expanding the screening program to include all women ages 15 to 24 years is considerably more expensive and only moderately more effective than screening only high-risk women.

Effect of clinical risk stratification on cost-effectiveness of the implantable cardioverter-defibrillator: the Canadian implantable defibrillator study.

BACKGROUND: Three randomized clinical trials showed that implantable cardioverter-defibrillators (ICDs) reduce the risk of death in survivors of ventricular tachyarrhythmias, but the cost per year of life gained is high. A substudy of the Canadian Implantable Defibrillator Study (CIDS) showed that 3 clinical factors, age >/=70 years, left ventricular ejection fraction /=2 of 3 risk factors. Incremental cost-effectiveness of ICD therapy was computed as the ratio of the difference in mean cost to the difference in life expectancy between the 2 groups. Over 6.3 years, the mean cost per patient in the ICD group was Canadian (C) $87 715 versus $38 600 in the amiodarone group (C$1 approximately US$0.67). Life expectancy for the ICD group was 4.58 years versus 4.35 years for amiodarone, for an incremental cost-effectiveness of ICD therapy of C$213 543 per life-year gained. The cost per life-year gained in patients with >/=2 factors was C$65 195, compared with C$916 659 with <2 risk factors. CONCLUSIONS: The cost-effectiveness of ICD therapy varies by patient risk factor status. The use of ICD therapy in patients who have >/=2 risk factors of age >/=70 years, left ventricular ejection fraction